a Department of Biochemical and Chemical Engineering , TU Dortmund University , Dortmund , Germany.
Pharm Dev Technol. 2019 Apr;24(4):487-493. doi: 10.1080/10837450.2018.1514522. Epub 2018 Sep 25.
The manufacturing of custom implants and patient-tailored drug dosage forms with fused deposition modeling (FDM) three-dimensional (3D) printing is currently considered to be very promising. Most FDM printers are designed as an open filament system, for which filaments with a defined size are required. In addition to this processing requirement, the filament material must be of medical or pharmaceutical quality, in order to be suitable in these applications. In this work, filaments with nominal diameters of 1.75 mm and diameter tolerances of ±0.05 mm or lower were developed in a continuous extrusion process. The filaments were made from different medical grade poly(lactic-co-glycolic acid) (PLGA) copolymers. Thermal characterization of the material with differential scanning calorimetry (DSC) showed increased material degradation with increasing hydrophilicity. Mechanical characterization of the filaments showed tensile strengths in the range of 41-48 MPa and Young's moduli in the range of 2055-2099 MPa. Stress relaxation tests showed no irreversible change in filament diameter under processing conditions similar to the utilized 3D printer. Due to unexpected differences in processability in the 3D printer, the molecular weight of the materials was identified as an additional relevant parameter.
使用熔融沉积成型(FDM)三维(3D)打印技术制造定制植入物和个体化药物剂量形式目前被认为很有前途。大多数 FDM 打印机设计为开放式丝材系统,需要使用具有特定尺寸的丝材。除了这个加工要求外,丝材材料必须具有医疗或制药质量,才能适用于这些应用。在这项工作中,通过连续挤出工艺开发了名义直径为 1.75mm、直径公差为±0.05mm 或更低的丝材。这些丝材由不同的医用级聚(乳酸-共-乙醇酸)(PLGA)共聚物制成。采用差示扫描量热法(DSC)对材料进行热特性分析表明,亲水性增加会导致材料降解增加。对丝材的力学特性分析表明,拉伸强度在 41-48MPa 范围内,杨氏模量在 2055-2099MPa 范围内。在类似于所使用的 3D 打印机的加工条件下进行的应力松弛测试表明,丝材直径没有发生不可逆的变化。由于在 3D 打印机中的加工性能存在意外差异,因此材料的分子量被确定为另一个相关参数。